Aseptic catheter and introducer



Oct. 27, 1964 R. L. ROWAN ETAL ASEPTIC CATHETER AND INTRODUCER 2Sheets-Sheet 1 Filed May 24, 1962 INVENTORS ROBERT L. ROWAN,M.D. YETTAROWAN BY mamfim A TTORNEY Oct. 27, 1964 R. L. ROWAN ETAL 3,154,080

ASELPTIC CATHETER AND INTRQDUCER Filed May 24, 1962 2 Sheets-Sheet 2INVENTORS YE TTA ROWAN ATTORNEY.

ROBERT LOUIS ROWAN, M.D.

United States Patent 3,154,080 ASEPTIC CATHETER AND HNTRODUCER Robert L.Rowan and Yetta Rowan, New York, N.Y., assignors to Rowlax Laboratories13., New York City, N.Y., a partnership Filed May 24, 1962, Ser. No.198,419 7 Claims. (Ql. 128349) The present application is acontinuation-in-part of the copending patent application Serial No.57,281, filed on September 20, 1960 and now abandoned.

The present invention relates to a urethral catheter and means formaintaining the catheter sterile before and during the removal of urinefrom patients.

The need for a device of the above-described character becomes apparentwhen one considers the difiiculties encountered in the sterile handlingof urethral catheters during catheterization. It is essential that thecatheter be maintained completely sterile during catheterization inorder to prevent any accidential infection of the patient from takingplace. This invariably requires the attending physician to put onsterile gloves before commencing the process of catheterization and alsoto take further timeconsuming precautionary measures.

Accordingly, it is an object of this invention to maintain a catheter ina sterile condition before use and to facilitate the collection of urineunder sterile conditions with this catheter from a patient.

It is a further object of this invention to collect the urine frompatients under sterile conditions without requiring the attendingphysician to put on sterile gloves.

Another object of this invention is to provide a novel combinationcatheter, introducer and urine collection container.

According .to the invention, this novel combination which is the subjectmatter of our invention, comprises a flexible plastic and preferablytransparent and thin container which houses a plastic stiffer cathetertube and a tubular introducer of easily deformable and, preferably,transparent material. In a first embodiment of the invention, thecontainer is of an elongated cylindrical shape. In this first embodimentthe tubular introducers outside diameter is slightly larger than theinside diameter of the plastic container so that the introducer isfirmly seated inside th container and does not by itself slidably movetherein. At least, one or more circular discs are rigidly secured insidethe introducer. Each of these discs have a central opening through whichprojects the catheter tube.

In a second modified form of the invention, the plastic, flexible, thinand transparent container also houses a plastic stiffer catheter tubeand a tubular introducer. The tubulm introducer, however, has adifferent configuration that the tubular introducer of the firstembodiment. This tubular introducers maximum outside diameter issubstantially smaller than the inside diameter of the elongated plasticcontainer and its minimum inside diameter is slightly larger than thmaximum outside diameter catheter tube so that the tubular introducermay be slidably moved along the catheter tube inside the plasticcontainer.

The entire unit is sterilized by heat, ultra-violet light or other meansknown in the art and is then closed by heatsealing means or other meansso that the unit remains in a sterilized condition. When the catheter isto be used, a strip is cut or torn from the upper portion of the plasticcontainer. The upper portion of the introducer is then manually fittedover the penis by manipulating the container and introducer. Thecatheter tube is then slowly inserted into the urethrae of the penis.The latter step is greatly facilitated when both the container andintroducer are transparent. When a desired amount of urine has beendeposited in the container, the cathether tube is removed from thecontainer by sliding the introducer and "ice the container back over thecatheter tube. The catheter tube may be left in the bladder until it hascompletely drained the latter. The container after removal may berescaled by clamping it below the introducer with staples or otherclosing devices. Alternatively, the urine may be transferred from thesterile plastic container to another sterile container or bottle. Theentire device thus is disposable and is meant to be used one time only.

The cathether tube, container and introducer may be made of any suitablenon-irritating plastic materials. It has been found that polyethylenehas all the required qualities for the various components of theinvention.

Although the present invention has been described in conjunction withpreferred embodiments, it is to be understood that the novel featureswhich are considered as characteristic for the invent-ion are set forthin particular in the appended claims. The construction and method ofoperation of the invention, however, will be best understood f-rom thefollowing description when read in connec tion with the accompanyingdrawings in which:-

FIG. 1 is a vertical-sectional elevation of the entire device;

FIG. 2 is a perspective view of the device, partially cut away,illustrating the manner of opening the container;

FIG. 3 is a perspective view of the device, showing the catheter tubeprotruding from the introducer;

FIG. 4 is a perspective View of a modified form of the device, partiallycut away;

FIG. 5 is a partial, vertical, sectional elevation along line 5 of FIG.4; and

FIG. 6 is a cross-section along line 6 of FIG. 4.

Referring now to the drawings in which identical parts are designatedwith the same numeral, the embodiment of FIGS. 1 to 3 has a catheter 1which is made of polyethylone or other suitable plastic material andconsists of a semi-rigid tube having a closed elliptical forward endportion with a small opening 2 and an open rear end portion 3. Thecatheter 1 is slidably mounted in the holes 4 of the introducer discs 5.The introducer discs 5 (two discs are illustrated in FIGS. 1, 2 and 3)are rigidly secured within the introducer tube 6 in axial alignmenttherewith. introducer discs 5 and introducer tube 6 consist ofrelatively rigid, but preferably elastic transparent plastic material.In-troducer tube 6, in turn, is seated in the plastic container 7. Thetube 6 is frictionally held in position in the container 7 due to thefact that the exterior diameter of tube 6 is slightly larger than theinterior diameter of the tubular container 7 when the latter is in anunstretched condition. The container 7 consists of flexible, preferablytransparent plastic material. The container '7 may be opened at one orboth ends by means of removing an opening strip 9 or a weakened portion9a of the plastic container 7. The catheter 1 and introducer tube 6 areslidably inserted into the flexible container 7 during the assembly ofthe device and the interior of the container 7 is then sterilized byultra-violet light, heat or other known means. After sterilization, thecontainer 7 is hermetically sealed by heat or other suitable means.

In FIGS. 46 a modified embodiment of the invention is illustrated. Thelatter modified embodiment is similar to the embodiment of FlGS. 1-3,except for the introducer tube 6a, which is shaped somewhat differentlythat the introducer tube 6. The latter is tubular in shape whereas theintroducer tube 6a has a tubular portion 6b and a frustro-conicalportion 6c. The interior diameter of the tubular portion 6b is slightlylarger than the exterior diameter of the catheter 1 so that theintroducer tube 6a may be slidably moved along the catheter 1. Thefrustroconical portion of the introducer tube 6a is shaped to fit overthe forward end of the penis of a patient. In the embodiment of FIGS. 46the container 7 has in lieu of an opening strip 9 weakened portions 9aat the loca- G tion of which the container 7 may be torn and therebyopened.

While it is possible to open the container 7 to remove the catheter 1for use by cutting oft" the end 8, it has been found preferable to usean opening strip 9. The latter slightly protrudes from the container 7,so that it may easily be grasped and then pulled off so that the end 3can be removed. The strip 9 may be made of the same or differentmaterial than the container 7, but preferably, like the container, ismade of polyethylene. The strip 9 is secured to the container 7 by heatwelding or can be made as an integral part of the container 7.

Upon opening of the container 7 by removing the end 8, or tearing thecontainer 7 open at weakened portion 9a, the frontal portion of thesterile introducer tube 6, 6a is immediately fitted over the front endof the penis and contamination of the patient during catheterization isthereby prevented. The fitting of the introducer tube over the penisfacilitated due to the flexibility of the introducer tube. After theintroducer tube is in place, the catheter 1 is inserted into the urethraby manipulating the deformable tube 6, 6a and the semi-rigid catheter1..

Although the present invention has been described in conjunction withpreferred embodiments, it is to be understood that modifications andvariations may be resorted to without departing from the spirit andscope of this invention, as those skilled in the art will readilyunderstand. Such modifications and variations are considered to bewithin the purview and scope of the invention and appended claims.

What we claim is:

1. An aseptic elongated container having a catheter and introducertherein, comprising in combination, an hermetically elongatedheat-sealed transparent plastic container, a hollow plastic tubularintroducer axially mounted in said container, a plastic catheterslidably mounted in said introducer, said introducer having at least onenonsupporting portion With respect to said catheter, at least a part ofwhich is of maximum interior diameter of said introducer, saidintroducer having at least one other supporting portion with respect tosaid catheter which includes a part of minimum interior diameter of saidintroducer, .at least a part of said non-supporting portion of saidintroducer being adapted to be manually fitted over the head of thepenis of a patient before said catheter is manually introduced into theurethra of a patient.

2. The aseptic elongated container having a catheter and introducer asset forth in claim 1, said hermetically heat-sealed plastic containerhaving a front end and including means operatively connected to saidfront end of said container for opening the same.

3. The aseptic elongated container having a catheter and introducer asset forth in claim 1, wherein said container and introducer are made ofplastic transparent material and wherein said introducer is made ofrelatively rigid elastic plastic material and said container andcatheter are made of relatively flexible plastic material, saidcontainer being made of more flexible plastic material than saidcatheter.

4. In the elongated disposable container, the aseptic catheter andintroducer, as set forth in claim 1, wherein said tubular introducer hastwo circular disc-shaped rib sections secured to the interior thereof inaxial alignment therewith, each of said two rib sections being spacedfrom the frontal portion of said introducer and having a centralopening, said catheter slidably extending through the central openingsof said rib sections.

5. In an elongated disposable container an aseptic catheter andintroducer, comprising in combination, an hermetically sealed flexibletransparent .tubular plastic container, the interior of said containerhaving been sterilzed before the sealing thereof, a transparent plastictubular introducer having interior walls supported in said container inaxial alignment therewith, said introducer having a frontal portion andat least one disc-shaped circular rib section spaced from said frontalportion and secured to said interior walls thereof, said rib sectionhaving an opening, a portion of said introducer forwardly projectingfrom said rib section and being adapted to be manually fitted over thehead of the penis of a patient and a catheter tube slidably extendingthrough said opening of said circular rib section.

6. An aseptic container, catheter and introducer, comprising incombination, an hermetically heat-sealed plastice tubular container, aplastic tubular introducer axially slidably mounted in said tubularcontainer, said introducer having an axial bore extending therethrough,a catheter slidably mounted in said bore of said introducer, saidintroducer having at least one portion of minimum interior diameter anda forwardly projecting other portion of maximum interior diameteradapted to be manually fitted over the head of the penis of a patientbefore said catheter is introduced into the urethra of a patient, saidformer portion of said introducer being adapted to slidably support saidcatheter.

7. The aseptic container catheter and introducer as set forth in claim6, including an annular peripheral opening strip secured by heat weldingto said container at the front end portion thereof whereby said frontend portion of said container can be removed from said container bytearing off said opening strip.

References Cited in the file of this patent UNITED STATES PATENTS1,120,549 Schellberg Dec. 8, 1914 2,547,758 Keeling Apr. 3, 19512,856,932 Griflitts Oct. 21, 1958 2,947,415 Garth Aug. 2, 1960 3,050,066Koehn Aug. 21, 1962

1. AN ASEPTIC ELONGATED CONTAINER HAVING A CATHETER AND INTRODUCERTHEREIN, COMPRISING IN COMBINATION, AN HERMETICALLY ELONGATEDHEAT-SEALED TRANSPARENT PLASTIC CONTAINER, A HOLLOW PLASTIC TUBULARINTRODUCER AXIALLY MOUNTED IN SAID CONTAINER, A PLASTIC CATHETERSLIDABLY MOUNTED IN SAID INTRODUCER, SAID INTRODUCER HAVING AT LEAST ONENONSUPPORTING PORTION WITH RESPECT TO SAID CATHETER, AT LEAST A PART OFWHICH IS OF MAXIMUM INTERIOR DIAMETER OF SAID INTRODUCER, SAIDINTRODUCER HAVING AT LEAST ONE OTHER SUPPORTING PORTION WITH RESPECT TOSAID CATHETER WHICH INCLUDES A PART OF MINIMUM INTERIOR DIAMETER OF SAIDINTRODUCER, AT LEAST A PART OF SAID NON-SUPPORTING PORTION OF SAIDINTRODUCER BEING ADAPTED TO BE MANUALLY FITTED OVER